REKINDLE Study

The Rekindle Study is a Phase 2, randomized, double-blind, parallel-group, dose-controlled clinical trial aimed at evaluating the safety and efficacy of a novel serotonergic antidepressant therapeutic candidate. Developed by a clinical-stage biopharmaceutical company, RE104 is an investigational psychedelic treatment that may support improved mental health for people experiencing adjustment disorder (AjD) following a major medical illness. The purpose of the study is to measure the effect of a single dose of RE104 (30 mg or 1.5 mg) administered as a SC injection for the treatment of AjD with depressed mood, or mixed anxiety and depressed mood in participants with cancer or other illnesses including ALS, MS, PD, or IPF. Participation in the study will span up to 70 days, including an up to 28-day screening window. It will consist of two pre-dosing preparatory sessions, an 8-hour dosing day, two post-dosing follow-up visits, and four additional surveying timepoints. A subset of participants will complete an entry interview and/or exit interview.

• Symptoms/Population: Adult patients with cancer or other medical illnesses (ALS, MS, PD, or IPF), who have adjustment disorder with depressed mood or mixed anxiety and depressed mood at DFCI Longwood and Chestnut Hill.
• Eligibility requirements:
  • Inclusion criteria: 18-80 years old; > 4-week history of adjustment disorder; diagnosis of cancer (no recent surgeries, radiotherapy, or cytotoxic chemotherapy), ALS, MS, PD, or IPF; PHQ-9 score of > 10 and MADRS score of > 20.
  • Exclusion criteria: current MDD/MDE; history of CNS malignancy; significant risk of suicide; history of psychiatric disorders with psychotic features; family history of psychosis or bipolar disorder; history of seizures; heart conditions/history of heart problems